Executive Director, CMC Strategy

Reporting to the Senior VP of Technical Operations, the Executive Director of CMC Strategy will work with the Tech Ops Core Team leads and external partners to establish overall CMC development strategies and timelines for all programs. They will also lead the effort to improve the efficiency and effectiveness of processes/procedures within Technical Operations. This is a senior position within Technical Operations and will be expected to leverage broad product and CMC development experience and leadership to support Kiniksa's portfolio and vision.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Job Responsibilities (including, but not limited to):

• Work with a diverse cross-functional group of partners, including Tech Ops Core Team leads, line function leads, project managers, Quality, Clinical Development, Regulatory Affairs, contract manufacturers, and contract testing labs etc. to establish overall portfolio of programs, including CMC development and manufacturing strategy, timelines, milestones, deliverables, risks, mitigations, decisions, lessons learned etc. May lead Tech Ops Core Team for one or multiple programs as needed.
• Establish strategy guidance documents and streamlined processes/procedures within Tech Ops to drive excellence and efficiency in development and operations.
• Collaborate with Regulatory Affairs on regulatory submission strategy. Lead and coordinate authoring and review of CMC sections/documents. Author and review regulatory submissions and correspondences as needed.
• Support alliance management activities with external vendors, contract manufacturers, and contract testing labs, including vendor assessment, contract review, and vendor performance management.
• Support quarterly budget process and department resource management.
• Represent Tech Ops in cross-functional meetings and provide updates to Senior Management and key stakeholders.
• Provide input on technical, regulatory, and manufacturing aspects as a leader within Technical Operations.
• Stay current with the regulatory guidance, industry trends, and new emerging technologies as it relates to biologics product development and manufacturing.

Qualifications:

• MS/PhD in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or related field
• Extensive experience (15+ years) in the biotech pharmaceutical industry, with expertise in CMC development and strategy for biologics (especially mAbs and therapeutic proteins) and progression of programs through clinical development and commercialization
• 10+ years in a leadership role, preferably as a CMC team lead for protein therapeutics programs with demonstrated record of success
• Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively
• Demonstrated experience in leading without authority and in leading strategic and transformative initiatives
• Strong technical/scientific experience in product development and commercialization
• Expertise in one or more technical areas of protein therapeutics development, such as upstream cell culture, downstream purification, analytical, drug product, formulation, or combination product
• Extensive experience with regulations and requirements such as cGMP, ICH, USP, JP and global CMC regulatory expectations and proven track-record of resolving complex issues with health authorities.
• Strong knowledge of phase appropriate regulatory requirements for biologics development. Experience authoring regulatory filings and interacting directly with Health Authorities
• Experience in CDMO and vendor evaluation/selection and alliance management
• Strategic thinker. Ability to understand technical, regulatory and business implications, as well as complex cross-functional considerations in establishing CMC development plans.
• Ability to balance near term objectives with long term goals, scenario plan, evaluate risks and benefits and develop effective solutions.
• Ability to manage multiple priorities and work with ambiguity to deliver results
• Ability to travel up to 5%
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.